Supporting a Pharmaceutical Greenfield Build from Planning to Commercialization
Client Overview
A global pharmaceutical company embarked on a significant greenfield project—a state-of-the-art GMP manufacturing facility designed to produce sterile products for global markets. The project included a complete technology transfer from an existing UK facility and the construction of a new GMP-compliant filling line. This high-stakes initiative demanded a specialized workforce with deep expertise in pharmaceutical startups and the adaptability to thrive in a fast-paced, ever-evolving environment.
Recognizing Baker Finn’s reputation for delivering high-caliber talent with greenfield and startup experience, the client partnered with us to source a multidisciplinary team to guide the project from the planning phase through to commercial production.
Project Objectives
- Deliver a fully operational GMP facility on time and within budget, aligned with regulatory requirements.
- Transfer technology, processes, and knowledge from the existing UK facility to the new site seamlessly.
- Build and validate a new sterile filling line to support commercial-scale production.
- Recruit a dynamic workforce capable of thriving in a greenfield startup environment.
The Importance of Greenfield Experience
Greenfield projects present unique challenges that demand more than technical expertise. The fast-paced, high-pressure environment requires individuals who can adapt to fluid roles, embrace hands-on responsibilities, and collaborate across functions to overcome unforeseen obstacles. Professionals with prior startup experience bring an invaluable “roll-up-your-sleeves” mentality, making them critical to the success of such projects.
Greenfield projects present unique challenges that demand more than technical expertise. The fast-paced, high-pressure environment requires individuals who can adapt to fluid roles, embrace hands-on responsibilities, and collaborate across functions to overcome unforeseen obstacles. Professionals with prior startup experience bring an invaluable “roll-up-your-sleeves” mentality, making them critical to the success of such projects.
Our Role
Baker Finn became the client’s trusted partner for sourcing specialized talent. Our team’s deep understanding of pharmaceutical capex greenfield builds and track record of finding professionals with startup experience allowed us to deliver exceptional value.
Baker Finn became the client’s trusted partner for sourcing specialized talent. Our team’s deep understanding of pharmaceutical capex greenfield builds and track record of finding professionals with startup experience allowed us to deliver exceptional value.
Key Roles Provided
The project required a broad range of skills across multiple disciplines. We sourced experienced professionals in the following key areas:
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Engineering and Instrumentation (E&I) Specialists
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- Designed and implemented advanced instrumentation for the sterile filling line.
- Supported integration of equipment with facility-wide automation systems.
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Calibration Engineers
- Established calibration programs for critical GMP equipment and utilities.
- Ensured compliance with regulatory requirements for process accuracy and reliability.
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Document Control Professionals
- Managed extensive documentation requirements, including design specifications, qualification protocols, and regulatory submissions.
- Streamlined documentation workflows to keep the project on schedule.
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Commissioning, Qualification, and Validation (CQV) Experts
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- Executed qualification protocols (IQ, OQ, PQ) for utilities, equipment, and systems.
- Ensured the facility met all regulatory standards and readiness for GMP production.
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Tech Transfer Specialists
- Facilitated seamless technology transfer from the UK site, ensuring knowledge retention and minimizing disruption.
- Adapted existing processes to align with the new facility’s design and capabilities.
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Project Managers with Greenfield Expertise
- Oversaw construction timelines, resource allocation, and stakeholder communication.
- Addressed challenges inherent to startup projects, including evolving scope and tight deadlines.
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Process Engineers
- Supported sterile filling line design, installation, and optimization.
- Worked cross-functionally to troubleshoot and refine production workflows.
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Construction and Startup Generalists
- Professionals with the ability to take on multiple roles in a fast-paced startup environment.
- Provided flexibility and problem-solving skills essential for the project’s dynamic needs.
Client Testimonial
“The professionals Baker Finn brought to our greenfield project were a perfect fit—not only technically skilled but also experienced in the unique challenges of a startup environment. Their ability to adapt, problem-solve, and roll up their sleeves made a significant difference. This project would not have been the same without their contributions.”
